SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert
SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert

SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert

Full-Time 60000 - 80000 £ / year (est.) Home office (partial)
Accurx

At a Glance

  • Tasks: Lead compliance efforts for medical devices and implement quality management systems.
  • Company: Accurx, a forward-thinking company in the heart of Shoreditch.
  • Benefits: Flexible office culture, generous holiday, and family support.
  • Other info: Join a dynamic team with opportunities for personal and professional growth.
  • Why this job: Make a real difference in healthcare by ensuring device compliance and quality.
  • Qualifications: Experience with class I-III medical devices and regulatory expertise.

The predicted salary is between 60000 - 80000 £ per year.

Accurx is seeking an experienced Compliance Lead to ensure compliance with UK MDR and implement Quality Management Systems. This role involves technical file ownership, regulatory strategy, and cross-functional collaboration.

Candidates should have experience with class I-III medical devices and a proven record in regulations.

Working at Accurx offers a flexible office culture in Shoreditch with numerous benefits, including generous holiday and family support.

SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert employer: Accurx

Accurx is an exceptional employer that champions a flexible office culture in the vibrant area of Shoreditch, providing employees with generous holiday allowances and robust family support. With a strong focus on professional development and cross-functional collaboration, Accurx empowers its team members to thrive in their roles while ensuring compliance with critical regulations in the medical device sector.
Accurx

Contact Detail:

Accurx Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert

Tip Number 1

Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at local meetups. We can’t stress enough how valuable personal connections can be in landing that Compliance Lead role.

Tip Number 2

Prepare for interviews by brushing up on UK MDR and ISO 13485 regulations. We recommend creating a cheat sheet of key points and examples from your experience with class I-III devices to showcase your expertise.

Tip Number 3

Don’t just apply anywhere—focus on companies like Accurx that align with your values and career goals. We suggest tailoring your approach to highlight how your skills can specifically benefit their compliance and quality management needs.

Tip Number 4

Follow up after interviews! A quick thank-you email reiterating your interest in the role and mentioning something specific from the conversation can set you apart. We believe this shows your enthusiasm and professionalism.

We think you need these skills to ace SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert

Compliance with UK MDR
Quality Management Systems (QMS)
Technical File Ownership
Regulatory Strategy
Cross-Functional Collaboration
Experience with Class I-III Medical Devices
Proven Record in Regulations
Attention to Detail

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the role of Compliance Lead. Highlight your experience with UK MDR, ISO 13485, and any relevant regulatory strategies you've implemented. We want to see how your background aligns with our needs!

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about compliance in the medical device sector and how your skills can benefit us at Accurx. Keep it engaging and personal!

Showcase Your Technical Expertise: Don’t forget to mention your experience with class I-III medical devices. We’re looking for someone who knows their stuff, so be specific about your technical file ownership and any successful projects you’ve led.

Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team. Let’s get started!

How to prepare for a job interview at Accurx

Know Your Regulations

Make sure you brush up on UK MDR, ISO 13485, and QMS standards. Be ready to discuss how your experience aligns with these regulations, especially regarding class I-III medical devices. This shows you’re not just familiar but also passionate about compliance.

Showcase Your Technical File Expertise

Prepare to talk about your experience with technical file ownership. Have specific examples ready that demonstrate your ability to manage documentation and ensure compliance. This will highlight your practical knowledge and problem-solving skills.

Emphasise Cross-Functional Collaboration

Accurx values teamwork, so be prepared to discuss how you've successfully collaborated with different departments in the past. Share examples of how you’ve worked with engineering, quality assurance, or regulatory teams to achieve compliance goals.

Ask Insightful Questions

At the end of the interview, don’t forget to ask questions! Inquire about Accurx’s approach to compliance challenges or how they foster a flexible office culture. This shows your genuine interest in the role and helps you assess if it’s the right fit for you.

SaMD Compliance Lead — MDR, ISO 13485 & QMS Expert
Accurx

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